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In five clinical studies of depo-subQ provera (medroxyprogesterone acetate) 104 involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 treated for up to 2 years), 9% of women discontinued treatment for adverse reactions. Among these 212 women, the most common reasons for discontinuation were:
- Uterine bleeding irregularities (35%, n=75)
- Increased weight (18%, n=39)
- Decreased libido (11%, n=23)
- Acne (10%, n=21)
- Injection site reactions (6%, n=12)
Adverse reactions reported by 5% or more of all women in these clinical trials included:
- Headache (9%)
- Intermenstrual bleeding (7%)
- Increased weight (6%)
- Amenorrhea (6%)
- Injection site reactions (5%)
Adverse reactions reported by 1% to < 5% of all women in these clinical trials included:
Nervous system disorders: dizziness, insomnia
Reproductive system and breast disorders: breast pain, breast tenderness, menometrorrhagia, menorrhagia, menstruation irregular, uterine hemorrhage, vaginal hemorrhage
Skin disorders: acne
Vascular disorders: hot flushes
There have been rare cases of osteoporosis including osteoporotic fractures reported postmarketing in patients taking DEPO-PROVERA Contraceptive Injection. In addition, infrequent voluntary reports of anaphylaxis and anaphylactoid reaction have been received associated with use of Depo-Provera CI (150 mg).
The following additional reactions have been reported with Depo-Provera Contraceptive Injection and may occur with use of depo-subQ provera 104:
Cardiac disorders: tachycardia
Gastrointestinal disorders: gastrointestinal disturbances, rectal bleeding
Hepato-biliary disorders: jaundice
Immune system disorders: allergic reaction
Investigations: decreased glucose tolerance
Psychiatric disorders: increased libido, nervousness
Reproductive system and breast disorders: breast lumps, galactorrhea, nipple discharge or bleeding, oligomenorrhea, prevention of lactation, prolonged anovulation, unexpected pregnancy, uterine hyperplasia, vaginal cyst
Read the Depo-SubQ Provera (medroxyprogesterone acetate) Side Effects Center for a complete guide to possible side effects
No drug-drug interaction studies have been conducted with depo-subQ provera (medroxyprogesterone acetate) 104. Aminoglutethimide administered concomitantly with depo-subQ provera (medroxyprogesterone acetate) 104 may significantly decrease the serum concentrations of MPA.
Read the Depo-SubQ Provera Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 7/28/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Depo-SubQ Provera Information
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